(332 days)
The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
The Xpeed AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type. The fixtures are made from CP Ti Grade 4, and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The fixtures are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The fixture is used as two stages, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration for multi-mount options. This system has 4.0, 4.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.2, 17.2mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.
The provided document is a 510(k) premarket notification for a medical device, the "Xpeed AnyRidge Internal Implant System." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a study proving the device meets those criteria, as one would find for a de novo device or a device requiring a PMA.
Therefore, the document does not report specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic device or a pass/fail threshold for a functional characteristic based on a clinical outcome. It also does not describe a study designed to prove the device meets such acceptance criteria based on its direct performance.
Instead, the document focuses on demonstrating that the modifications made to the manufacturing process do not affect the substantial equivalence of the subject device to its predicate devices. The "acceptance criteria" discussed are primarily related to general device characteristics and compliance with standards.
Here's an analysis based on the information provided, recognizing that the scope of this document is different from a typical performance study report:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, there are no statistical performance metrics (e.g., accuracy, sensitivity, specificity) or specific quantitative clinical "acceptance criteria" presented for the Xpeed AnyRidge Internal Implant System. The "performance" assessment is based on demonstrating that the manufacturing process modifications do not alter the established characteristics of the device compared to its predicates.
Therefore, a table of this nature cannot be generated from the provided text. The document lists tests performed and states that results met the criteria of the standard, which serves as a general statement of acceptance for each test.
| Test Item | Acceptance Standard/Criteria | Reported Device Performance |
|---|---|---|
| Appearance | In-house standard | Met the criteria of the standard |
| Dimension | In-house standard | Met the criteria of the standard |
| Packaging | ISO 11607 | Met the criteria of the standard |
| Extraction | USP | Met the criteria of the standard |
| Sterility | USP | Met the criteria of the standard |
| Biocompatibility (Acute systemic toxicity) | ISO 10993-11 | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Biocompatibility (Sensitization) | ISO 10993-10 | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Biocompatibility (Intracutaneous reactivity) | ISO 10993-10 | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Biocompatibility (Implantation) | ISO 10993-6 | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Surface analysis (XPS) | In-house standard | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Surface analysis (EPMA) | In-house standard | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Surface analysis (XRD) | In-house standard | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Surface analysis (ICP) | In-house standard | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Surface analysis (SEM) | In-house standard | Non-clinical testing results demonstrate substantial equivalence to predicate device |
| Surface roughness | In-house standard | Non-clinical testing results demonstrate substantial equivalence to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "non-clinical test data" which includes appearance, dimension, packaging, extraction, sterility, biocompatibility, and surface analysis tests.
- Sample Size: The specific sample sizes for these tests are not provided in the document.
- Data Provenance: This refers to in-vitro/bench testing ("in-house standard," ISO standards, USP standards). It is not clinical data (e.g., patient data). The country of origin for the data is not explicitly stated beyond the manufacturer being in South Korea. This is not retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the tests described are non-clinical, bench-top tests, not clinical evaluations requiring expert interpretation of results or establishment of ground truth in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable as the tests described are non-clinical, bench-top tests. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies involving human readers or expert consensus on patient cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device is an endosseous dental implant system, not a diagnostic AI device that involves human readers or assessment of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical dental implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" implicitly refers to the specified criteria or limits defined by the referenced standards (e.g., ISO 11607 for packaging, USP for extraction, ISO 10993 series for biocompatibility, and in-house standards for others). There is no "expert consensus, pathology, or outcomes data" in the clinical sense for these bench tests.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As mentioned above, this document does not describe the development of an AI/ML model.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.